A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors (NCT06292208) | Clinical Trial Compass
RecruitingPhase 1/2
A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors
China48 participantsStarted 2024-03-09
Plain-language summary
Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).
Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).
Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.
Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.
Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18 to 80 years old.
. Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumor or non-Hodgkin lymphoma who have failed or have no standard therapy, or for whom the standard therapy is intolerant.
. There is at least one assessable tumor lesion in the dose escalation phase and at least one measurable lesion in the dose expansion phase according to RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas) (tumor lesions located in areas of prior radiotherapy or other localized regional treatment areas are generally not considered as measurable lesions unless the lesion shows definite progression or persists after 3 months of radiotherapy).
. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
. Have a life expectancy of at least 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD
Timeframe: through study completion, an average of 1 year
2
DRDE
Timeframe: through study completion, an average of 1 year
3
Dose limiting toxicity (DLT)
Timeframe: 28 days after first dose(dose-escalation phase)
4
RP2D
Timeframe: through study completion, an average of 1 year
5
ORR
Timeframe: through study completion, an average of 1 year
. Have adequate organ function as indicated by the following laboratory values.
. Hematological (no transfusion or hematopoietic stimulating factor therapy within 14 days): absolute neutrophil count (ANC)≥1.5×109/L, platelet count (PLT)≥ 90 ×109/L, hemoglobin (HGB)≥90 g/L;
. Hepatic: total bilirubin (TBIL)≤1.5×upper limit of normal (ULN), except for Gilbert syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3.0×ULN, or ALT and AST ≤ 5.0×ULN in patients with liver metastases or liver cancer;
Exclusion criteria
. Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or any excipient contained in the drug or vehicle formulation for IBD0333.
. History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune costimulatory molecule agonist.
. History of anti-cancer therapies prior to the initiation of investigational product (chemotherapy within 3 weeks; radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks) and the following are except:
. Nitrosourea or mitomycin C within 6 weeks prior to the initiation of investigational product;
. Oral fluorouracil and small molecule-targeted drugs within 2 weeks prior to the initiation of investigational product;
. Chinese patent drugs within 2 weeks prior to the initiation of investigational product.
. History of investigational anti-cancer drug within 4 weeks prior to the initiation of investigational product.
. History of major surgery (except for puncture biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product, or require the selective surgery during the trial.